# FDA recall D-0558-2022

> **Lannett Company, Inc.** · Class II · drug recall initiated 2022-02-09.

## Product

Diazepam Oral Solution (Concentrate), 25 mg per 5 mL (5 mg/mL), 30 mL BOTTLE and DROPPER, Rx Only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 0527-1768-36.

## Reason for recall

Failed Impurities/Degradation Specifications: Out of specification results for related substances.

## Distribution

Product was distributed nationwide in the USA.

## Key facts

- **Recall number:** D-0558-2022
- **Recalling firm:** Lannett Company, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2022-02-09
- **Report date:** 2022-02-23
- **Termination date:** 2023-05-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Philadelphia, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0558-2022

## Citation

> AI Analytics. FDA recall D-0558-2022. Retrieved 2026-06-14 from https://api.ai-analytics.org/recall/D-0558-2022. Source: US FDA. Licensed CC0.

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